ClinicalTrials.gov
ClinicalTrials.gov Menu

What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158664
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : July 8, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.

Condition or disease Intervention/treatment Phase
Dental Implants Device: 0.6 mm tread pitch implant Device: 0.1 mm tread pitch implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
Study Start Date : January 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rosin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 0.6 mm tread pitch implant Device: 0.6 mm tread pitch implant
0.6 mm tread pitch implant will be used
Experimental: 0.1 mm tread pitch implant Device: 0.1 mm tread pitch implant
0.1 mm tread pitch implant will be used



Primary Outcome Measures :
  1. To document the outcome of bone remodeling around IBT implants [ Time Frame: 3 years after implantation ]

Secondary Outcome Measures :
  1. To clinically and radiographically document the placement of both IBT implant thread types in the same patient [ Time Frame: over 2 years ]
  2. 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation [ Time Frame: over 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Periodontally-healthy or periodontally-treated patients
  • Smokers are included
  • All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.

Exclusion Criteria:

  • All other contra indications for implant surgery
  • Guided bone regeneration or use of any substitutes
  • No implantation in regenerated or augmented bone
  • No immediate loading cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158664


Contacts
Contact: Hugo De Bruyn, PhD hugo.debruyn@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Hugo De Bruyn, PhD         
Sub-Investigator: Eric Thevissen         
Sub-Investigator: Jan Cosyn         
Sub-Investigator: Stefan Vandeweghe         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01158664     History of Changes
Other Study ID Numbers: 2009/649
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
dental implants
different tread pitch design